Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies. (MODISC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01694134
First received: September 22, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

The treatment of chronic low back pain is a major objective of public healthcare, because it causes an important number of sick leaves. A correlation between clinical observations and an inflammatory discopathy has been underlined, but there is currently any reference treatment. In this study, the main objective is to assess the efficacy of an intradiscal injection of corticoids versus local anaesthetic on the treatment of pain of patients with low back pain associated to a Modic I discopathy.


Condition Intervention Phase
Low Back Pain
Lumbago
Modic I Discopathy
Drug: Hydrocortancyl.
Drug: Lidocaine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Assessment of the Efficacy of an Intradiscal Injection of Corticoids in Modic I Discopathies.

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Pain assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The pain will be assessed by the visual analog scale (VAS).


Secondary Outcome Measures:
  • Quality of life assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Quality of life will be assessed by the self-questionnaire SF-36.

  • Consumption of analgesics and NSAIDs assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Specific low back pain parameters assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Low back pain parameters will be assessed by the Dallas scale and the Oswestry scale.


Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Corticoids
A group of patients will receive an intradiscal injection of Hydrocortancyl.
Drug: Hydrocortancyl.
Patients will receive an intradiscal injection of hydrocortancyl.
Sham Comparator: Local anaesthetic
A group of patients will receive an intradiscal injection of Lidocaine.
Drug: Lidocaine

Detailed Description:

This is a randomized, controlled, single-blind with two arms (anaesthetic versus corticoids) trial.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 80 years
  • Signed Informed consent
  • Low back pain for more than 6 months associated with Modic I discopathy (diagnosed by MRI)

Exclusion Criteria:

  • Past history of lumbar surgery
  • Patient under anticoagulant or antisludge treatment, or with coagulation troubles
  • Patient with unbalanced diabetes mellitus (blood glucose > 1.30 g/l)
  • Patient with unstabilized high blood pressure (> 160/95 mmHg)
  • Patient with evolving infection
  • Patient with iodine allergy or one of the Hydrocortancyl® or Lidocaine components
  • Porphyria, hypersensitivity to local anaesthetic
  • Patient with sphincter troubles showing a cauda equine syndrome
  • Untreated psychotic state
  • Pregnant women or of childbearing age without effective contraception means
  • Impossible 6 months follow-up
  • Participation to another trial
  • Vulnerable persons protected by the law
  • Persons under guardianship
  • Persons unable to express their consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694134

Contacts
Contact: Isabelle Tavares, MD +334 67 33 88 26 i-tavaresfigueiredo@chu-montpellier.fr

Locations
France
Hospital University of Montpellier Recruiting
Montpellier, France, 34000
Contact: Isabelle Tavares, MD    +334 67 33 88 26    i-tavaresfigueiredo@chu-montpellier.fr   
Principal Investigator: Isabelle Tavares, MD         
Sponsors and Collaborators
University Hospital, Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01694134     History of Changes
Other Study ID Numbers: 8833
Study First Received: September 22, 2012
Last Updated: April 10, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by University Hospital, Montpellier:
Discopathy
Modic I
Corticoids
Local Anaesthetic
Intradiscal injection

Additional relevant MeSH terms:
Intervertebral Disc Displacement
Back Pain
Low Back Pain
Intervertebral Disc Degeneration
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical
Anesthetics, Local
Lidocaine
Anesthetics
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014